Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085762
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/17/1977 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2010 SUPPL-62 Labeling-Container/Carton Labels

Label is not available on this site.

04/15/1998 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

05/09/1997 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

06/05/1995 SUPPL-49 Labeling

Label is not available on this site.

12/29/1993 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

08/15/1990 SUPPL-46 Labeling

Label is not available on this site.

01/31/1990 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

11/17/1987 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/09/1983 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

TABLET;ORAL; 0.025MG;2.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 086727 ANI PHARMS INC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 210819 BAYSHORE PHARMS LLC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 085372 LANNETT
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 085762 MYLAN
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 040357 PAR PHARM
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 210571 UPSHER SMITH LABS
LOMOTIL ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription Yes AA 012462 GD SEARLE LLC

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